Guidable intravascular blood pump and related methods

• US 10,357,598 B2
• Filed: 10/22/2018
• Issued: 07/23/2019
• Est. Priority Date: 09/03/1999
• Status: Expired due to Fees

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Inventors: Aboul-Hosn, Walid N., Kanz, William R., Baker, Bruce A.
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US16/167,400
• Publication Number:
  US 20190054224A1
• Time in Patent Office: 274 Days
• CPC Class Codes: A61M 2025/0177 having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2205/3348 Pressure measurement using a water column
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 60/13 by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/221 the blood flow through the rotating member having both radial and axial components, e.g. mixed flow pumps
• CPC Class Codes: A61M 60/237 the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
• CPC Class Codes: A61M 60/414 transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
• CPC Class Codes: A61M 60/422 the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
• CPC Class Codes: A61M 60/523 using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/531 using blood pressure data, e.g. from blood pressure sensors
• CPC Class Codes: A61M 60/825 Contact bearings, e.g. ball-and-cup or pivot bearings
• CPC Class Codes: A61M 60/827 Sealings between moving parts
• CPC Class Codes: A61M 60/829 having a purge fluid supply
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: Y10S 415/90 Rotary blood pump

Abstract

An improved intravascular blood pump and related methods involving the broad inventive concept of equipping the intravascular blood pump with guiding features such that the intravascular blood pump can be selectively positioned at a predetermined location within the circulatory system of a patient.

Claims

1. An intravascular blood pump system, comprising:

a blood pump comprising a rotor having a rotor hub, at least one blade extending outward from the rotor hub, and a shroud within which the rotor is at least partially rotatably disposed;

a catheter coupled to the blood pump;

a cannula that is coupled to the blood pump;

one or more first ports and one or more second ports establishing fluid communication between a lumen of the cannula and an exterior region of the cannula, wherein at least one first port of the one or more first ports is located in proximity to the rotor and at least one second port of the one or more second ports is spaced apart from and located distal to the at least one first port, wherein the cannula is configured such that when the blood pump is positioned in the patient to provide left-heart support a distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and a proximal end of the cannula and the at least one first port are positioned in the patient'"'"'s aorta, and the blood pump is configured to draw blood from the patient'"'"'s heart into the at least one second port through the cannula lumen and out the at least one first port to provide left-heart support while the cannula is positioned across an aortic valve of the patient; and

a distal tip, wherein the distal tip is pigtail shaped or J-shaped, and when the blood pump is positioned in the patient to provide left-heart support the distal tip is wholly within a left ventricle of the patient.

2. The intravascular blood pump system of claim 1, further comprising:

a guide mechanism comprising a lumen having a proximal end and a distal end, the guide mechanism adapted to guide a distal portion of the intravascular blood pump system to a predetermined location within a circulatory system of the patient;

wherein the guide mechanism is configured to allow for a guide wire to slideably advance therealong.

3. The intravascular blood pump system of claim 2, wherein the guide mechanism is configured such that the guide wire passes through the region delimited by the outer cannula surface at a location proximal to where the guide wire establishes slidable contact with the guide mechanism, and wherein a proximal end of the distal tip is fixed or attached to a distal end of the cannula.

4. The intravascular blood pump system of claim 2, wherein at least a portion of the lumen of the guide mechanism is located proximal to the distal tip.

5. The intravascular blood pump system of claim 1, further comprising:

a blood pressure detection mechanism comprising a fluid column disposed within the catheter and configured to detect a pressure of blood proximate the intravascular blood pump.

6. The intravascular blood pump system of claim 5, wherein the blood pressure detection mechanism comprises at least one of a piezo-electric pressure sensing element and a strain gauge, and wherein the pressure sensing element is adjacent to the one or more first ports.

7. The intravascular blood pump system of claim 1, wherein a distal portion of the shroud has an outer diameter matching an inner diameter of a proximal portion of the cannula, and the proximal portion of the cannula is disposed about a distal portion of the shroud, wherein at least a proximal portion of the shroud has the same outer diameter as the proximal portion of the cannula.

8. An intravascular blood pump system, comprising:

a blood pump adapted to be guided to a predetermined location within a circulatory system of a patient by a guide wire and configured to provide left-heart support, the blood pump comprising a rotor having a rotor hub and at least one blade extending outward from the rotor hub, and a shroud within which the rotor is at least partially rotatably disposed;

a catheter coupled to the blood pump;

a cannula that is coupled to the blood pump, one or more first ports and one or more second ports establishing fluid communication between a lumen of the cannula and an exterior region of the cannula, wherein at least one first port is located in proximity to the rotor and at least one second port is spaced apart from and located distal to the at least one first port, wherein the cannula is configured such that when the blood pump is positioned in the patient to provide left-heart support a distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and a proximal end of the cannula and the at least one first port are positioned in the patient'"'"'s aorta, and the blood pump is configured to draw blood from the patient'"'"'s heart into the at least one second port through the cannula lumen and out the at least one first port to provide left-heart support while the cannula is positioned across an aortic valve of the patient; and

a pressure sensing element configured to sense pressure proximate the intravascular blood pump, wherein the pressure sensing element comprises at least one of a piezo-electric pressure sensing element and a strain gauge,

wherein a distal portion of the shroud has an outer diameter matching an inner diameter of a proximal portion of the cannula, and the proximal portion of the cannula is disposed about a distal end portion of the shroud, and wherein at least a proximal portion of the shroud has the same outer diameter as the proximal portion of the cannula.

9. The intravascular blood pump system of claim 8, further comprising:

an elongate lumen sized to slidably receive the guide wire and dimensioned such that the guide wire passes slidably through the elongate lumen, the elongate lumen is sized smaller cross sectionally than the cannula lumen, both the elongate lumen and the cannula lumen not extending through the rotor hub or the catheter, the guide wire not passing through the rotor hub or the catheter, and the guide wire extending out of the intravascular blood pump system in the distal direction through the elongate lumen.

10. The intravascular blood pump system of claim 9, further comprising:

a motor assembly and a drive cable, the drive cable at least partially disposed within the catheter,

wherein the motor assembly and drive cable are configured to drive the rotor,

wherein the elongate lumen is proximal to the cannula and the motor assembly is configured to remain external to the patient, and

wherein the intravascular blood pump system comprises a dual construction arrangement whereby the rotor is configured to be docked within the shroud, and wherein the elongate lumen is an integral extension of a wall of the cannula.

11. The intravascular blood pump system of claim 9, wherein the elongate lumen is adapted to guide the guide wire through a distal end of the intravascular blood pump system.

12. The intravascular blood pump system of claim 9, wherein the elongate lumen is one or more of shorter in length than the cannula lumen and an extension of a wall of the cannula.

13. The intravascular blood pump system of claim 9, wherein the elongate lumen is at least partially disposed within an outer surface of the cannula and wherein the intravascular blood pump system is configured for the guide wire to exit the intravascular blood pump system through an end of the elongate lumen.

14. The intravascular blood pump system of claim 9, having a distal tip, wherein the distal tip is pigtail shaped or J-shaped, and when the blood pump is positioned in the patient to provide left-heart support the distal tip is wholly within a left ventricle of the patient.

15. The intravascular blood pump system of claim 8, wherein the pressure sensing element further comprises a fluid column disposed within the catheter.

16. The intravascular blood pump system of claim 8, wherein the pressure sensing element is adjacent to the one or more first ports.

17. An intravascular blood pump system, comprising:

a blood pump adapted to be guided to a predetermined location within a circulatory system of a patient by a guide wire and configured to provide left-heart support, the blood pump comprising a rotor having a rotor hub and a shroud at least partially disposed about the rotor hub, and at least one blade extending outward from the rotor hub;

a catheter coupled to the blood pump;

a cannula coupled to the blood pump, wherein one or more first ports and one or more second ports are in fluid communication between a lumen of the cannula and an exterior region of the cannula, wherein at least one first port of the one or more first ports is located in proximity to the rotor and at least one second port of the one or more second ports is spaced apart from and located distal to the at least one first port, and the cannula is configured such that when the blood pump is positioned in the patient to provide left-heart support a distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and a proximal end of the cannula and the at least one first port are positioned in the patient'"'"'s aorta, and the blood pump is configured to draw blood from the patient'"'"'s heart into the at least one second port through the cannula lumen and out the at least one first port to provide left-heart support while the cannula is positioned across an aortic valve of the patient;

a pressure sensing element configured to sense pressure proximate the blood pump; and

a distal tip, wherein the distal tip is pigtail shaped or J-shaped, and when the blood pump is positioned in the patient to provide left-heart support the distal tip is wholly within a left ventricle of the patient.

18. The intravascular blood pump system of claim 17, further comprising:

an elongate lumen sized to slidably receive the guide wire and dimensioned such that the guide wire passes slidably through the elongate lumen, the elongate lumen is sized smaller cross sectionally than the cannula lumen and is shorter in length than the cannula lumen, both the elongate lumen and the cannula not extending through the rotor hub or the catheter, the guide wire not passing through the rotor hub or the catheter, and the guide wire extending out of the intravascular blood pump system in the distal direction through the elongate lumen.

19. The intravascular blood pump system of claim 18, further comprising:

a motor assembly and a drive cable, the drive cable at least partially disposed within the catheter,

wherein the motor assembly and drive cable are configured to drive the rotor,

wherein the elongate lumen is proximal to the cannula and the motor assembly is configured to remain external to the patient, and

wherein the intravascular blood pump system comprises a dual construction arrangement whereby the rotor is configured to be docked within the rotor shroud.

20. The intravascular blood pump system of claim 18, wherein the elongate lumen is an extension of a wall of the cannula.

21. The intravascular blood pump system of claim 18, wherein the elongate lumen is adapted to guide the guide wire through a distal end of the intravascular blood pump system.

22. The intravascular blood pump system of claim 18, wherein the elongate lumen is at least partially disposed within an outer surface of the cannula and wherein the intravascular blood pump system is configured for the guide wire to exit the intravascular blood pump system through an end of the elongate lumen.

23. The intravascular blood pump system of claim 17, wherein the pressure sensing element comprises a fluid column extending through the catheter, and at least one of a piezo-electric pressure sensing element and a strain gauge, wherein the pressure sensing element is adjacent to the one or more first ports, and

a distal portion of the shroud has an outer diameter matching an inner diameter of a proximal portion of the cannula, the proximal portion of the cannula disposed about a distal portion of the shroud, and at least a proximal portion of the shroud has the same outer diameter as the proximal portion of the cannula.

24. An intravascular blood pump system, comprising:

a blood pump adapted to be guided to a predetermined location within a circulatory system of a patient by a guide wire and configured to provide left-heart support, the blood pump comprising a rotor having a rotor hub and a rotor shroud at least partially disposed about the rotor hub, and at least one blade extending outward from the rotor hub;

a catheter coupled to the blood pump;

a cannula coupled to the blood pump, a distal portion of the rotor shroud having an outer diameter matching an inner diameter of a proximal portion of the cannula, the proximal portion of the cannula disposed about a distal portion of the rotor shroud, and at least a proximal portion of the rotor shroud has the same outer diameter as the proximal portion of the cannula, one or more first ports and one or more second ports establishing fluid communication between a lumen of the cannula and an exterior region of the cannula, wherein at least one first port of the one or more first ports is located in proximity to the rotor and at least one second port of the one or more second ports is spaced apart from and located distal to the at least one first port, wherein the cannula is configured such that when the blood pump is positioned in the patient to provide left-heart support a distal end of the cannula and the at least one second port are positioned inside the patient'"'"'s heart and a proximal end of the cannula lumen and the at least one first port are positioned in the patient'"'"'s aorta, wherein the intravascular blood pump is configured to draw blood from the patient'"'"'s heart into the at least one second port through the cannula and out the at least one first port to provide left-heart support while the cannula is positioned across an aortic valve of the patient, wherein the guide wire does not pass through the rotor hub or the catheter;

a pigtail shaped distal tip or a J-shaped distal tip, wherein when the intravascular blood pump is positioned in the patient to provide left-heart support the pigtail shaped distal tip or the J-shaped distal tip is wholly within a left ventricle of the patient; and

a pressure sensing element configured to sense pressure proximate the intravascular blood pump comprising a fluid column extending through the catheter.

25. The intravascular blood pump system of claim 24, wherein the pressure sensing element comprises at least one of a piezo-electric pressure sensing element and a strain gauge, wherein the pressure sensing element is adjacent to the one or more first ports.

26. The intravascular blood pump system of claim 24, further comprising an elongate lumen sized to slidably receive the guide wire and dimensioned such that the guide wire passes slidably through the elongate lumen, the elongate lumen is sized smaller cross sectionally than the cannula lumen and is shorter in length than the cannula, both the elongate lumen and the cannula lumen not extending through the rotor hub or the catheter.

27. The intravascular blood pump system of claim 26, further comprising:

a motor assembly and a drive cable, the drive cable at least partially disposed within the catheter,

wherein the motor assembly and drive cable are configured to drive the rotor,

wherein the elongate lumen is proximal to the cannula and the motor assembly is configured to remain external to the patient, and

wherein the intravascular blood pump system comprises a dual construction arrangement whereby the rotor is configured to be docked within the rotor shroud.

28. The intravascular blood pump system of claim 26, wherein the elongate lumen is an extension of a wall of the cannula.

29. The intravascular blood pump system of claim 26, wherein the elongate lumen is at least partially disposed within an outer surface of the cannula and wherein the intravascular blood pump system is configured for the guide wire to exit the intravascular blood pump system through an end of the elongate lumen.

30. The intravascular blood pump system of claim 26, wherein at least a portion of the elongate lumen is located proximal to the pigtail shaped distal tip or the J-shaped distal tip.